# K090477: Alpine Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Sanacor
- Decided: Jul 27, 2009 after 153 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K061577 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061577: Ovaltwist Pedicle Screw System, Signus Medizintechnik GmbH (2006) Summary page 1.
- (no number) MESA Pedicle Screw System: named in the summary without a submission number

## Most influential descendants
- K160820: PressON Pro Spinal Fixation System (2016), 0 descendants of its own

## Indications for use
The Alpine Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K090477
Methodology: https://510kreport.com/methodology